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Amgen yet to find home-rrun product despite research.


Faced with slowing sales of its two primary products, Amgen Inc., the Thousand Oaks-based biotech company, has intensified its search for super-profitable drugs.

But so far, the firm has been unable to find anything approaching the promise of Epogen and Neupogen, the two drugs that transformed Amgen into a pharmaceutical powerhouse.

The company is working on treatments for everything from hepatitis C Hepatitis C Definition

Hepatitis C is a form of liver inflammation that causes primarily a long-lasting (chronic) disease. Acute (newly developed) hepatitis C is rarely observed as the early disease is generally quite mild.
 and cancer to spinal-cord injuries and Parkinson's disease Parkinson's disease or Parkinsonism, degenerative brain disorder first described by the English surgeon James Parkinson in 1817. When there is no known cause, the disease usually appears after age 40 and is referred to as Parkinson's disease.  - and is especially encouraged about leptin Leptin
A protein hormone that affects feeding behavior and hunger in humans. At present it is thought that obesity in humans may result in part from insensitivity to leptin.
, a fat-fighting drug that would tap into the multibillion-dollar weight-loss market.

In a recently-released study by Tufts University, patients who had daily doses of leptin, a naturally-occurring protein believed to regulate body fat, lost an average of 16 pounds over six months. Amgen officials said they have decided to proceed to a second phase of tests on humans.

"We're very optimistic and very encouraged," said Andrea Rothschild, manager of corporate communications.

Analysts who follow the stock, however, are less impressed.

"It doesn't sound that great, and a daily injection ... is a fairly severe treatment for not a lot of weight loss," said Robert M. LeBoyer, an analyst at Genesis Merchant Group Securities in San Francisco.

Added Kris Jenner, an analyst for T. Rowe Price T. Rowe Price (NASDAQ: TROW) is an independent global investment management firm and mutual fund manager based in Baltimore, Maryland. It was founded in 1937 by Thomas Rowe Price, Jr..

T.
 Associates, "I think it certainly has the potential to improve. But I think if you were trying to predict the future, I see this being a product used by the most severely obese category, where 5 to 10 percent loss in body weight would be significant," he said.

Sales growth of Epogen, the company's $1.1 billion-a-year treatment that enables kidney and cancer patients to increase their production of red blood cells Red blood cells
Cells that carry hemoglobin (the molecule that transports oxygen) and help remove wastes from tissues throughout the body.

Mentioned in: Bone Marrow Transplantation

red blood cells 
, has slowed from 21 percent in 1996 to 8 percent last year, due in part to changes in Medicare reimbursement.

Sales growth of Neupogen, a product that restores depleted de·plete  
tr.v. de·plet·ed, de·plet·ing, de·pletes
To decrease the fullness of; use up or empty out.



[Latin d
 white blood cell levels in chemotherapy and AIDS patients, fell from 12 percent in 1995 to 4 percent in 1997, in part because improved AIDS therapies have reduced the market for the treatment.

"In many people's minds, you can't take (Amgen's) current revenue stream and project it out seven to 10 years," said Jenner. "What does Amgen have to do? I think they have to have at least one product in the pipeline, and preferably two, that will generate peak revenue of $500 million or more."

That's why Amgen is spending $630 million a year to fuel a research-and-development effort that has resulted in several new products. "We have quite a full pipeline of products in phase 1 to phase 3 trials," said Rothschild. "We're constantly looking."

Last year, the Food and Drug Administration approved the sale of Amgen's third product, Infergen, after the company had gone six years without introducing a new drug. The product helps fight the hepatitis C virus
This page is for the virus. For the disease, see Hepatitis C.
The Hepatitis C virus (HCV) is a small (50 nm in size), enveloped, single-stranded, positive sense RNA virus in the family Flaviviridae.
.

LeBoyer, though, sees the drug as more of a base hit than a home run. By his estimate, Infergen could bring in about $15 million a year. "I don't see it as having a major significance. The company has a $2.3 billion earning stream without it," he said.

Amgen is also about to market Stemgen, a growth factor that helps stimulate the production of stem cells stem cells, unspecialized human or animal cells that can produce mature specialized body cells and at the same time replicate themselves. Embryonic stem cells are derived from a blastocyst (the blastula typical of placental mammals; see embryo), which is very young , which in turn help produce new blood cells blood cells,
n.pl the formed elements of the blood, including red cells (erythrocytes), white cells (leukocytes), and platelets (thrombocytes).


blood cells

See erythrocyte and leukocyte. Platelets are classed separately.
. The product could be used to boost a cancer patient's supply of stem cells in the bloodstream. Doctors could then remove a couple of pints of the stem cell-rich blood, for transfusion after the patient undergoes high-dose chemotherapy high-dose chemotherapy Oncology The administration of chemotherapeutics in excess of BM toxicity; given the risk of aplastic anemia, HDC requires autologous BMT and use of 'rescue' factors such as G-CSF, GM-CSF, and erythropoietin. See Bone marrow transplantation. .

The product has made it through three phases of rigorous human tests, and the company has filed an application with the FDA FDA
abbr.
Food and Drug Administration


FDA,
n.pr See Food and Drug Administration.

FDA,
n.pr the abbreviation for the Food and Drug Administration.
 for regulatory approval, a process that could be completed as early as this year.

Rothschild said the company does not make revenue projections, but she conceded the drug won't likely match sales of Neupogen, given that there are relatively few high-dose chemotherapy patients.

According to Jenner, the company's best near-term bet is MGDF MGDF Megakaryocyte Growth and Development Factor , a copy of a protein that produces blood-clotting platelets in the blood stream. The product could be used to help cancer patients combat serious bleeding that occurs when their platelets are killed by chemotherapy.

MGDF is in Phase 3 of clinical testing, and officials say early results look promising.

Jenner sees the product capable of generating as much as $300 million in annual revenue - still short of the big blockbuster the company needs.
COPYRIGHT 1998 CBJ, L.P.
No portion of this article can be reproduced without the express written permission from the copyright holder.
Copyright 1998, Gale Group. All rights reserved. Gale Group is a Thomson Corporation Company.

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Author:Woodard, Christopher
Publication:Los Angeles Business Journal
Date:Jun 29, 1998
Words:724
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